FibroScan ® Study: Assessing Liver Fibrosis in Patients Using Methotrexate for Psoriasis

Overview

The purpose of this study is to validate FibroScan and FibroSURE™ as equal or superior alternatives to liver biopsy for the monitoring and detection of methotrexate-induced hepatic fibrosis and cirrhosis in patients with moderate-to-severe psoriasis.

Full Title of Study: “A Prospective, Validation Study of FibroSURE™ and FibroScan® as Screening, Detection, and Monitoring Alternatives to Liver Biopsy for Methotrexate-induced Hepatic Fibrosis and Cirrhosis in Patients With Psoriasis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 15, 2019

Detailed Description

The goals of this study are to validate FibroScan and FibroSURE™ as equal or superior alternatives to liver biopsy. The goal is to evaluate the monitoring and detection of methotrexate-induced hepatic fibrosis and cirrhosis in patients with moderate-to-severe psoriasis.

Interventions

  • Diagnostic Test: Fibroscan and Fibrosure
    • Patient’s will undergo fibroscan and fibrosure to test their liver for the level of liver fibrosis as measured by these tests. Fibroscan uses vibrations sent through the liver to measure its stiffness and the fibrosure uses laboratory and demographic parameters to create a score associated with a certain level of fibrosis. The scores from these tests will then be compared to the amount of fibrosis noted on a standard of care liver biopsy.

Arms, Groups and Cohorts

  • Other: Patients undergoing Fibroscan and Fibrosure
    • Patient’s will undergo fibroscan and fibrosure to test their liver for the level of liver fibrosis as measured by these test. The scores from these tests will then be compared to the amount of fibrosis noted on a standard of care liver biopsy.

Clinical Trial Outcome Measures

Primary Measures

  • Fibrosis Score Correlation
    • Time Frame: 5 years
    • The correlation between the clinical fibrosis scores generated by the FibroScan® and FibroSURE™ alone and in combination to the METAVIR fibrosis score generated from the histologic review of a liver biopsy performed for the assessment of liver fibrosis in a psoriasis patient who reaches a cumulative methotrexate dose of 1g.

Secondary Measures

  • Fibrosis Score Validity to Liver Biopsy Results
    • Time Frame: 5 years
    • Determine if the clinical fibrosis scores generated by the FibroScan® and FibroSURE™ alone and in combination can be safely used as alternatives to performing a liver biopsy when screening for liver fibrosis in psoriasis patients who have reached a cumulative methotrexate dose of 1 gram

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female greater than or equal to 18 years of age – Must have a diagnosis of moderate-to-severe psoriasis – Newly starting methotrexate Exclusion Criteria:

  • Allergy to methotrexate – History of chronic alcohol abuse – Diagnosis of liver disease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospitals Cleveland Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Neil Korman, Director, Clinical Trials Unit – University Hospitals Cleveland Medical Center
  • Overall Official(s)
    • Neil Korman, MD, Principal Investigator, University Hospitals Cleveland Medical Center

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